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Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools (BEST)

Primary Purpose

Tobacco Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Student-Intervention only group
Multi-component Intervention
Control Group
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder focused on measuring Tobacco use, Adolescents, Primary prevention, Program effectiveness, Parental component

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

School Inclusion Criteria A school is eligible for the study if

  • it is located in Berlin
  • has 7th grade classes (students between 12-15 years)

School Exclusion Criteria:

  • schools offers an extensive smoking prevention program for their students that includes parental involvement.
  • schools that do not agree to stop visiting the KARUNA e.V. smoking parcours (if they do) for the next two years in case of being randomized to the control group.
  • schools that do not agree to have a parents' night (separate or part of the typical parents' nights) where trained health coaches will introduce and discuss the topic of smoking prevention in youth in case of being randomized to the combined student-parent intervention.

Student Inclusion Criteria A student is eligible for the study if

  • Female or male in the 7th grade
  • Signed written assent
  • Intellectual and physical ability of participant to make an informed decision about study participation
  • Attends one of the participating schools
  • Has signed approval from parent/caregiver

Sites / Locations

  • Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health EconomicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Student-intervention only group

Multi-component intervention

Control Group

Arm Description

Schools randomized to intervention only (arm 1) will agree to visit the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?"). One school class of students will visit the parcours once during a school day. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.

Schools randomized to the student-parent intervention arm also will agree to visit the KARUNA e.V. smoking prevention parcours. In addition, the schools will agree to have one parents' night presented by trained health coaches informing parents about smoking prevention topics in youth during the school year. Trained health coaches will give an evaluated smoking prevention presentation for parents at the parents' nights at the end of the first school year. Also, participating parents will receive information about successful ways to prevent smoking and promote smoking cessation in their children once by mail.

Schools randomized to the control school will be offered to participate in the nutrition and exercise prevention program offered by KARUNA e.V. during the 2-year study.

Outcomes

Primary Outcome Measures

Percentage of regular smokers among students at the 2 year follow-up assessment.
The primary study outcome is the percentage of regular smokers among students at the 2 year follow-up assessment.

Secondary Outcome Measures

Students' attitudes towards smoking and smoking-related self-efficacy
The secondary study outcomes are attitudes towards smoking and smoking-related self-efficacy. In addition, we will assess the acceptability of the program components. Other secondary outcomes include: Percentage of 7th graders that started smoking during the study period. Percentage of 7th graders that stopped smoking during the study period. Percentage of 7th graders that are smoking less at the 2 year assessment compared to baseline assessment. Percentage of 7th graders that are smoking more at the 2 year assessment compared to baseline assessment.

Full Information

First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Charite University, Berlin, Germany
Collaborators
Senatsverwaltung für Bildung, Wissenschaft und Forschung, Berlin, Germany, KARUNA prevents, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01306552
Brief Title
Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools
Acronym
BEST
Official Title
BEST Prevention Study. "Berlin Evaluates School Tabacco Prevention" Study Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Senatsverwaltung für Bildung, Wissenschaft und Forschung, Berlin, Germany, KARUNA prevents, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effectiveness of a combined parent-student program for smoking prevention in 7th graders in Berlin schools.
Detailed Description
The hazardous health effects of smoking and second hand smoke are well known and published. Despite wide spread tobacco prevention campaigns and initiatives, the proportion of children and adolescents who smoke remains high, especially in Germany. Current research indicates that comprehensive strategies, especially with a parental involvement component, appear to be the most effective school-based smoking prevention programs. A popular smoking prevention program in the city of Berlin is the Karuna interactive show jumping course "Still smoking or already alive?" ("Rauchst du noch oder lebst du schon?" Mitmach - Parcours). This parcours was designed to teach facts about smoking and its health-damaging effects, its negative effects on physical appearance, to promote communication and to enhance participants' awareness of social pressure and their self-efficacy to deal with these situations. No study to date has evaluated its effectiveness in reducing smoking rates among participating students. The study aim is to test the effectiveness of an interactive combined student-parent intervention in 7th graders regarding the reduction of smoking rates among secondary school children aged 12-15 compared to no smoking prevention intervention using self-reported questionnaires. In addition, it will be tested whether the program that involves the combination of a student and a parent intervention is more effective in the reduction of smoking rates in comparison to a program without a parental intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Tobacco use, Adolescents, Primary prevention, Program effectiveness, Parental component

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Student-intervention only group
Arm Type
Active Comparator
Arm Description
Schools randomized to intervention only (arm 1) will agree to visit the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?"). One school class of students will visit the parcours once during a school day. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.
Arm Title
Multi-component intervention
Arm Type
Active Comparator
Arm Description
Schools randomized to the student-parent intervention arm also will agree to visit the KARUNA e.V. smoking prevention parcours. In addition, the schools will agree to have one parents' night presented by trained health coaches informing parents about smoking prevention topics in youth during the school year. Trained health coaches will give an evaluated smoking prevention presentation for parents at the parents' nights at the end of the first school year. Also, participating parents will receive information about successful ways to prevent smoking and promote smoking cessation in their children once by mail.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Schools randomized to the control school will be offered to participate in the nutrition and exercise prevention program offered by KARUNA e.V. during the 2-year study.
Intervention Type
Behavioral
Intervention Name(s)
Student-Intervention only group
Intervention Description
One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") during 7th grade. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.
Intervention Type
Behavioral
Intervention Name(s)
Multi-component Intervention
Intervention Description
One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") + one parent night with information about smoking prevention and one informational letter by mail
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
One visit to the Nutrition and Physical Activity Parcours offered by KARUNA e.V. ("Kinderleicht gesund zu leben"). (same set up as the smoking prevention parcours with topics around healthy nutrition and promotion of physical activity)
Primary Outcome Measure Information:
Title
Percentage of regular smokers among students at the 2 year follow-up assessment.
Description
The primary study outcome is the percentage of regular smokers among students at the 2 year follow-up assessment.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Students' attitudes towards smoking and smoking-related self-efficacy
Description
The secondary study outcomes are attitudes towards smoking and smoking-related self-efficacy. In addition, we will assess the acceptability of the program components. Other secondary outcomes include: Percentage of 7th graders that started smoking during the study period. Percentage of 7th graders that stopped smoking during the study period. Percentage of 7th graders that are smoking less at the 2 year assessment compared to baseline assessment. Percentage of 7th graders that are smoking more at the 2 year assessment compared to baseline assessment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
School Inclusion Criteria A school is eligible for the study if it is located in Berlin has 7th grade classes (students between 12-15 years) School Exclusion Criteria: schools offers an extensive smoking prevention program for their students that includes parental involvement. schools that do not agree to stop visiting the KARUNA e.V. smoking parcours (if they do) for the next two years in case of being randomized to the control group. schools that do not agree to have a parents' night (separate or part of the typical parents' nights) where trained health coaches will introduce and discuss the topic of smoking prevention in youth in case of being randomized to the combined student-parent intervention. Student Inclusion Criteria A student is eligible for the study if Female or male in the 7th grade Signed written assent Intellectual and physical ability of participant to make an informed decision about study participation Attends one of the participating schools Has signed approval from parent/caregiver
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Falk Mueller-Riemenschneider, MD
Phone
+4930450529036
Email
Falk.Mueller-Riemenschneider@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christin Buerger
Phone
+49 30450529125
Email
Christin.Buerger@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan N Willich, MD
Organizational Affiliation
Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Falk Mueller-Riemenschneider, MD
Phone
+49 30450529036
Email
Falk.Mueller-Riemenschneider@charite.de
First Name & Middle Initial & Last Name & Degree
Christin Buerger
Phone
+49 30450529125
Email
Christin.Buerger@charite.de
First Name & Middle Initial & Last Name & Degree
Stefan N. Willich, MD
First Name & Middle Initial & Last Name & Degree
Falk Müller-Riemenschneider, MD, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
27447693
Citation
Krist L, Lotz F, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN, Muller-Riemenschneider F. Long-term effectiveness of a combined student-parent and a student-only smoking prevention intervention among 7th grade school children in Berlin, Germany. Addiction. 2016 Dec;111(12):2219-2229. doi: 10.1111/add.13537. Epub 2016 Sep 19.
Results Reference
derived
PubMed Identifier
25150368
Citation
Muller-Riemenschneider F, Krist L, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN. Berlin evaluates school tobacco prevention - BEST prevention: study design and methodology. BMC Public Health. 2014 Aug 23;14:871. doi: 10.1186/1471-2458-14-871.
Results Reference
derived

Learn more about this trial

Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools

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